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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)
Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Loss of consciousness (2418)
Event Date 04/12/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8709sc, lot# n275013009, implanted: (b)(6) 2010, explanted: (b)(6) 2018, product type: catheter. Product id: 8709sc, serial/lot #: (b)(4), udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via manufacturer representative regarding a patient who was receiving baclofen (500 mcg/day, 1250 mcg/ml), morphine (1500 mcg/day, 3750 mcg/ml) and bupivacaine (10000 mcg/day, 25000 mcg/ml) via intrathecal drug delivery pump for an unknown indication for use. It was reported that the patient presented to the emergency room on (b)(6) 2018 exhibiting signs of baclofen withdrawal (return of spasticity, difficulty breathing and swallowing). The symptoms progressed until the patient lost consciousness. The patient had gone in for refill on (b)(6) 2018. Her managing physician turned off the pump and sent her home with oral medications. There were no known diagnostics or troubleshooting performed. The patient's pump showed it was at end of service (eos) "in 2 months. " a decision was made to replace the pump and reinitiate baclofen therapy. During the replacement procedure, the catheter could not be aspirated, so a new catheter was also placed. It was unknown whether the issue was resolved at the time of this report. The explanted pump would not be returned; it was discarded by the customer. The tip of the catheter remained in the patient. It did not come out easily and was clamped off. The explanted portion of the catheter was discarded by the customer. The patient status at the time of this report was "alive - with injury. " the patient returned to the intensive care unit and remained intubated. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare professional via manufacturer representative. It was reported that the patient was doing well and continued to improve. X-ray imaging of the catheter in-vivo was performed as a diagnostic. No further complications were reported.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7432825
MDR Text Key105562684
Report Number3004209178-2018-08103
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2012
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/04/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/16/2018 Patient Sequence Number: 1
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